"Lactobacillus Crispatus M247, LSIL and Microbiota"

NCT05808816 | Unknown Phase 4

• 1 other identifier: ID 4010
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m

Conditions

Vaginal Flora Imbalance; ASC-US; LSIL; HPV Infection

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of Lactobacillus Crispatus M247 oral supplementation to change the genetic profile of the vaginal microbiota of patients with low-grade lesions from HPV, by XBIOGem test.

  5 months

Secondary Outcomes (3)

• Cytological regression and microbiological clearance of HPV infection

  5 months

• Evaluate the applicability in clinical practice of the XBIOGem test in the characterization of the vaginal microbiota in this type of patient

  24 months

• Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota

  24 months

Study Arms (2)

Arm A

EXPERIMENTAL

Patient with oral supplementation of Lactobacillus Crispatus M247

Drug: Lactobacillus Crispatus M247

Arm B

NO INTERVENTION

Patients without oral supplementation of Lactobacillus Crispatus M247

Interventions

Lactobacillus Crispatus M247 DRUG

Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related

Arm A

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pap smear ASCUS or L-SIL
• HPV test + (HPV-HR e/o HPV-LR)

You may not qualify if:

• Hormonal therapy (OC, ring, patch, implant)
• Pregnancy status
• Immunosuppressive therapies
• Ongoing HPV vaccination

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Atypical Squamous Cells of the Cervix; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Cervical Dysplasia; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes

Central Study Contacts

Rosa Pasqualina RP De Vincenzo, Phd

CONTACT

+0039 3393660390; rosapasqualina.devincenzo@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: June 16, 2021
• Primary Completion: February 2, 2023
• Study Completion: June 30, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-02

Locations

IT (1)